- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion, Enrollment change, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov) - Aug 2, 2023 P2, N=34, Completed, Carrier-mediated dosages may differ from normal formulations because they are rarely studied. Active, not recruiting --> Completed | N=60 --> 34
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment change, Trial withdrawal, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer (clinicaltrials.gov) - Jun 12, 2023 P2, N=0, Withdrawn, Toxicity was generally manageable, with common adverse events including fatigue, nausea, and anemia. N=115 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment closed, Trial completion date, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov) - Nov 2, 2022 P2, N=60, Active, not recruiting, Initiation date: Jul 2022 --> Apr 2023 Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Mar 2023
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Feb 8, 2022 P2, N=3, Completed, Completed --> Terminated; Study was closed for toxicity. Trial completion date: Feb 2022 --> Jun 2021 | Trial primary completion date: Feb 2022 --> May 2021
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion, Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Feb 4, 2022 P2, N=3, Completed, Trial completion date: Feb 2022 --> Jun 2021 | Trial primary completion date: Feb 2022 --> May 2021 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2022 | Trial primary completion date: Dec 2022 --> Feb 2022
- |||||||||| NLG207 / Ellipses Pharma, Avastin (bevacizumab) / Roche
Clinical, P1/2 data, PK/PD data, Journal, Combination therapy: A phase Ib/II and pharmacokinetic study of EP0057 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (Pubmed Central) - Aug 6, 2021 P1/2 EP0057 exhibits high plasma drug retention, slow clearance, and controlled slow release of CPT from the polymer when administered alone and with paclitaxel. (NCT02389985) 242 words.
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial primary completion date, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov) - Jul 6, 2021 P2, N=60, Recruiting, (NCT02389985) 242 words. Trial primary completion date: Jul 2022 --> Nov 2022
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment closed, Enrollment change, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Jun 30, 2021 P2, N=3, Active, not recruiting, Trial primary completion date: Jul 2022 --> Nov 2022 Recruiting --> Active, not recruiting | N=30 --> 3
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Apr 22, 2021 P2, N=30, Recruiting, The current analysis provides a strong foundation for future study as a potential predictive tool in ongoing NLG207 clinical trials. Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Dec 2022
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment open, Combination therapy, BRCA Biomarker, PARP Biomarker, Metastases: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov) - Dec 16, 2020 P2, N=60, Recruiting, Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Dec 2022 Not yet recruiting --> Recruiting
- |||||||||| NLG207 / Ellipses Pharma
Journal: Measurement of NLG207 (formerly CRLX101) nanoparticle-bound and released camptothecin in human plasma. (Pubmed Central) - Dec 1, 2020 P1/2, P2 NLG207 NDCs demonstrated significant rates of CPT release in human plasma at room temperature after 2 h but were shown to be stable at 4 °C for 24 h and through 4 freeze/thaw cycles. This assay was used to quantitate CPT plasma concentrations in clinical samples to confirm clinical utility following NLG207 treatment in subjects with advanced prostate cancer.
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial termination, Metastases: Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer (clinicaltrials.gov) - Nov 3, 2020 P1/2, N=32, Terminated, This assay was used to quantitate CPT plasma concentrations in clinical samples to confirm clinical utility following NLG207 treatment in subjects with advanced prostate cancer. Active, not recruiting --> Terminated; The study was halted prematurely at the funding partner's request.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Apr 15, 2020 P2, N=30, Recruiting, Active, not recruiting --> Terminated; The study was halted prematurely at the funding partner's request. Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
- |||||||||| CRLX 101 / NewLink Genetics
Journal: Establishment of a Tm-shift Method for Detection of Cat-Derived Hookworms. (Pubmed Central) - Apr 13, 2019 ...To establish a Tm-shift method for the detection of Ancylostoma ceylanicum and A. tubaeforme in cats, specific primers, with GC tail of unequal length attached to their 5 Ì end, were designed based on 2 SNP loci (ITS101 and ITS296) of the internal transcribed spacer 1 (ITS1) sequences...In the clinical detection of hookworm in 69 stray cat fecal sample, the Tm-shift detection results were consistent with the microscopic examination and successfully differentiated between the 2-hookworm species. In conclusion, the developed method is a rapid, sensitive and accurate technique and can provide a promising tool for clinical detection and epidemiological investigation of cat-derived hookworms.
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion date, Trial termination, Trial primary completion date, Combination therapy: A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - Feb 25, 2019 P1/2, N=30, Terminated, In conclusion, the developed method is a rapid, sensitive and accurate technique and can provide a promising tool for clinical detection and epidemiological investigation of cat-derived hookworms. Trial completion date: Aug 2017 --> Oct 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2017 --> Jun 2018; Company decision
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment change, Trial completion date, Trial termination, Combination therapy, Metastases: Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors (clinicaltrials.gov) - Feb 25, 2019 P1, N=41, Terminated, Trial completion date: Aug 2017 --> Oct 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2017 --> Jun 2018; Company decision N=61 --> 41 | Trial completion date: Dec 2017 --> May 2018 | Active, not recruiting --> Terminated; Company decision
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Dec 13, 2018 P2, N=30, Recruiting, N=61 --> 41 | Trial completion date: Dec 2017 --> May 2018 | Active, not recruiting --> Terminated; Company decision Trial completion date: Mar 2020 --> Jun 2020 | Trial primary completion date: Mar 2020 --> Jun 2020
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma, Avastin (bevacizumab) / Roche
Trial completion, Trial primary completion date, Combination therapy, Metastases: CRLX101 Plus Bevacizumab in Advanced RCC (clinicaltrials.gov) - Aug 29, 2018 P1b, N=22, Completed, Trial completion date: Jun 2020 --> Mar 2020 Active, not recruiting --> Completed | Trial primary completion date: Jun 2014 --> Jul 2017
- |||||||||| NLG207 / Ellipses Pharma, Avastin (bevacizumab) / Roche
Clinical, P2 data, Journal, Combination therapy: A randomized phase 2 trial of CRLX101 in combination with bevacizumab versus standard of care in patients with advanced renal cell carcinoma. (Pubmed Central) - Mar 4, 2018 P2 Within the SOC arm, patients received single-agent bevacizumab (19), axitinib (18), everolimus (7), pazopanib (4), sorafenib (4), sunitinib (2), or temsirolimus (2)...Further development in this disease is not planned. NCT02187302 (NIH).
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors (clinicaltrials.gov) - Apr 20, 2017 P1, N=61, Active, not recruiting, Phase classification: P1/2 --> P1b/2a Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Oct 2017
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment closed, Trial primary completion date, Metastases: Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer (clinicaltrials.gov) - Mar 21, 2017 P1/2, N=71, Active, not recruiting, Terminated --> Withdrawn Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Oct 2016
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma, Avastin (bevacizumab) / Roche
Enrollment change, Trial primary completion date, Combination therapy: CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer (clinicaltrials.gov) - Feb 16, 2017 P2, N=63, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Oct 2016 N=29 --> 63 | Trial primary completion date: Apr 2016 --> Mar 2017
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